Table 1 Patient and Tumor Characteristics

From: Efficacy, safety, and predictive biomarkers of neoadjuvant nab-paclitaxel and pembrolizumab in hormone receptor-positive breast cancer: A randomized pilot trial

Characteristic

Overall (n = 29)

No of patients (%)

Arm A: Chemo first (n = 15)

No of patients (%)

Arm B: Pembro first (n = 14)

No of patients (%)

Age, years - Median (range)

42 (31-70)

46 (31-70)

41.5 (31-53)

Sex

 Female

29 (100.0%)

15 (100.0%)

14 (100.0%)

Race

 White

26 (89.7%)

14 (93.3%)

12 (85.7%)

 Asian

2 (6.9%)

0 (0.0%)

2 (14.3%)

 More than one race

1 (3.4%)

1 (6.7%)

0 (0.0%)

Ethnicity

 Hispanic or Latino

1 (3.4%)

1 (6.7%)

0 (0.0%)

 Non-Hispanic

26 (89.7%)

13 (86.7%)

13 (92.9%)

 Unknown

2 (6.9%)

1 (6.7%)

1 (7.1%)

Overall clinical stage*

 II

20 (69.0%)

10 (66.7%)

10 (71.4%)

 III

9 (31.0%)

5 (33.3%)

4 (28.6%)

Clinical T stage

 T2

20 (69.0%)

10 (66.7%)

10 (71.4%)

 T3

8 (27.6%)

4 (26.7%)

4 (28.6%)

 T4

1 (3.4%)

1 (6.7%)

0 (0.0%)

Clinical N stage

 N0

8 (27.6%)

5 (33.3%)

3 (21.4%)

 N1

21 (72.4%)

10 (66.7%)

11 (78.6%)

HR status**

 HR-positive

24 (82.8%)

13 (86.7%)

11 (78.6%)

 HR low-positive

5 (17.2%)

2 (13.3%)

3 (21.4%)

HER2 status

 Negative

29 (100.0%)

15 (100.0%)

14 (100.0%)

Histology

 Ductal

22 (75.9%)

11 (73.3%)

11 (78.6%)

 Lobular

4 (13.8%)

3 (20.0%)

1 (7.1%)

 Ductal + lobular

3 (10.3%)

1 (6.7%)

2 (14.3%)

Grade

 1

2 (6.9%)

1 (6.7%)

1 (7.1%)

 2

14 (48.3%)

7 (46.7%)

7 (50.0%)

 3

12 (41.4%)

7 (46.7%)

5 (35.7%)

 Unknown

1 (3.4%)

0 (0.0%)

1 (7.1%)

Additional (non-trial) neoadjuvant therapy given

 Yes

15 (51.7%)

9 (60.0%)

6 (42.9%)

 No

14 (48.3%)

6 (40.0%)

8 (57.1%)

Additional neoadjuvant regimen administered

 AC x 4 cycles

14 (48.3%)

8 (53.3%)

6 (42.9%)

 AC and pembro x 4 cycles

1 (3.4%)

1 (6.7%)

0 (0.0%)

Breast surgery

 Lumpectomy

12 (41.4%)

6 (40.0%)

6 (42.9%)

 Mastectomy

16 (55.2%)

8 (53.3%)

8 (57.1%)

 No breast surgery

1 (3.4%)

1 (6.7%)

0 (0.0%)

Adjuvant radiation

 Yes

18 (62.1%)

11 (73.3%)

7 (50.0%)

 No

11 (37.9%)

4 (26.7%)

7 (50.0%)

  1. *Based on AJCC clinical anatomic staging.
  2. **HR status considered positive if ER or PR ≥ 10%. Otherwise, considered low-positive. HR-negative patients were not eligible and not enrolled.
  3. HR hormone receptor, HER2 human epidermal growth factor receptor 2, AC (adriamycin/cyclophosphamide), pembro pembrolizumab.
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